Biohaven and Vigeo Now Enrolling in GBM
AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate
Interventions for Patients With Glioblastoma
Global Coalition for Adaptive Research (LARKSPUR, CA), Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), and Vigeo
Therapeutics -- The Global Coalition for Adaptive Research (GCAR)
in collaboration with Biohaven and Vigeo Therapeutics, today
announced the activation of Biohaven's troriluzole and Vigeo's
VT1021 in GBM AGILE (Glioblastoma Adaptive Global Innovative
Learning Environment). GBM AGILE is a revolutionary
patient-centered, adaptive platform trial for registration that
tests multiple therapies for patients with newly-diagnosed and
recurrent glioblastoma (GBM) – the deadliest form of brain
cancer.
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Biohaven's troriluzole and Vigeo's VT1021 are entering the GBM
AGILE trial, which initially opened in July 2019 and has screened
over 1200 patients to date. Troriluzole and VT1021 will enroll
patients with newly-diagnosed and recurrent glioblastoma.
Dr. Michael Lim, Chair of the Department of Neurosurgery at
Stanford University and Dr. Michael Weller, Director Department of
Neurology, University Hospital Zurich, Switzerland will serve as
arm Principal Investigators for troriluzole’s evaluation in GBM
AGILE. VT1021 will be led by arm Principal Investigators, Dr.
Howard Colman, Professor, Huntsman Cancer Institute and Department
of Neurosurgery, University of Utah, and Dr. Tom Mikkelsen, Medical
Director, Precision Medicine Program & Clinical Trials Office,
Henry Ford Health.
“GBM AGILE is a ground-breaking trial that enables us to
simultaneously and dynamically study the effects of multiple new
drug candidates in an optimized learning environment. The trial’s
nimble model allows us to more efficiently and rapidly identify
effective therapies for GBM patients,” said Dr. Michael Lim, who
also serves as a member of the GBM AGILE Arm Identification and
Selection Committee. “We are excited to include troriluzole and
VT1021 in GBM AGILE. These investigational drugs have the potential
to support improved outcomes for GBM patients, who desperately need
more effective treatment options.”
GBM AGILE is an international, innovative platform trial
designed to more rapidly identify and confirm effective therapies
for patients with glioblastoma through response adaptive
randomization and a seamless phase 2/3 design. The trial, conceived
by over 130 key opinion leaders, is conducted under a master
protocol, allowing multiple therapies or combinations of therapies
from different pharmaceutical partners to be evaluated
simultaneously. With its innovative design and efficient
operational infrastructure, data from GBM AGILE can be used as the
foundation for a new drug application (NDA) and biologics license
application (BLA) submissions and registrations to the FDA and
other health authorities.
The new interventions are opening first at Henry Ford Health
Cancer in Detroit under Henry Ford site Principal Investigator Dr.
Tom Mikkelsen and will subsequently open at more than 40 trial
sites across the United States with additional global sites to
follow.
“Glioblastoma is a devasting disease with few effective
treatment options and no cure. Currently the average survival rate
is estimated to be only eight months,” noted Dr. Mikkelsen. “We are
enthusiastic to be the first site to activate troriluzole and
VT1021 in the GBM AGILE study. We are committed to finding our
patients the best possible treatments.”
Biohaven’s troriluzole is a novel, orally administered small
molecule that modulates glutamate, the most abundant excitatory
neurotransmitter in the human body. Troriluzole is thought to
restore glutamate homeostasis by enhancing glutamate cycling,
decreasing presynaptic glutamate release, and augmenting the
expression and function of excitatory amino acid transporters
(i.e., EAAT2) located on glial cells that play a key role in
clearing excess glutamate from the synapse. Troriluzole was
selected for inclusion in GBM AGILE, based on compelling evidence
showing deregulation of glutamate in glioblastoma. The therapeutic
potential of troriluzole in glioblastoma and other oncology
indications is supported by several recent clinical and
translational research studies conducted with troriluzole and its
active moiety.
“The initiation of this pivotal trial of troriluzole for
glioblastoma is an exciting milestone,” commented Dr. Vlad Coric,
Chairman and Chief Executive Officer of Biohaven. “We are extremely
proud to be joining the highly innovative GBM AGILE trial. We look
forward to collaborating with the Principal Investigators, Drs. Lim
and Weller, the team at GCAR, and the GBM AGILE trial sites in
order to rapidly advance the development of troriluzole in
combination with standard of care therapies as a novel treatment
for people suffering from glioblastoma, which is amongst the most
recalcitrant and lethal of all cancers.”
Vigeo’s VT1021, is a first-in-class dual modulating compound
that blocks the CD47 immune checkpoint and activates the apoptotic
and macrophage reprogramming activity of CD36. The result of the
dual modulating activity is the induction of apoptosis in tumor and
endothelial cells, as well as an increase in both CTL:Treg and
M1:M2 macrophage ratio. The biological/therapeutic activity of
VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1).
Through these dual-modulating effects VT1021 reprograms the tumor
microenvironment from one that is immune suppressive, or “cold,” to
immune enhanced (or sensitized), or “hot,” that are more
susceptible to attack from the immune system. With its novel
mechanism of action and clinical data from a Phase 2 expansion
study in recurrent GBM patients, VT1021 is undergoing further
studies to determine its effect in treating the disease, given that
CD36 and CD47 are found to be highly expressed in tumor cells
compared to normal brain tissue. Vigeo is developing VT1021 as a
therapeutic agent across a range of cancers, with a current focus
on solid tumors.
“VT1021 has seen remarkable patient response, with a great
safety profile, in our earlier clinical trials. We are excited that
VT1021 is included as part of this global, multi-site effort to
treat such a devastating disease,” said Jim Mahoney, Chief
Executive Officer, Vigeo Therapeutics. “The opportunity to work
with these distinguished Principal Investigators and to test our
drug in both newly diagnosed and recurrent GBM patient populations
are key factors in our decision to join AGILE.”
About Global Coalition for Adaptive Research (GCAR)
The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3)
nonprofit organization uniting physicians, clinical researchers,
advocacy and philanthropic organizations, biopharma, health
authorities, and other key stakeholders in healthcare to expedite
the discovery and development of treatments for patients with rare
and deadly diseases by serving as Sponsor of innovative and complex
trials including master protocols and platform trials. GCAR is the
sponsor of GBM AGILE, an adaptive platform trial for patients with
GBM – the most common and deadliest of malignant primary brain
tumors. Key strategic partners for the GBM AGILE trial effort
include the National Brain Tumor Society, National Foundation for
Cancer Research, Asian Fund for Cancer Research, and Cure Brain
Cancer Foundation, four nonprofit organizations that are working
together to provide philanthropic support as well as assistance in
communicating with patients and families and inviting all others to
join in supporting this innovating approach to brain tumor
treatment development. To learn more about GCAR, visit
gcaresearch.org
About Biohaven
Biohaven is a global commercial-stage biopharmaceutical company
with a portfolio of innovative, best-in-class therapies to improve
the lives of patients with debilitating neurological and
neuropsychiatric diseases, including rare disorders. Biohaven's
Neuroinnovation™ portfolio includes FDA-approved NURTEC® ODT
(rimegepant) for the acute and preventive treatment of migraine
(EMA-approved as VYDURA® for the acute treatment of migraine with
or without aura, and prophylaxis of episodic migraine in adults who
have at least four migraine attacks per month) and a broad pipeline
of late-stage product candidates across five distinct mechanistic
platforms: CGRP receptor antagonism for the acute and preventive
treatment of migraine and other CGRP-mediated diseases; glutamate
modulation for obsessive-compulsive disorder and spinocerebellar
ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral
sclerosis; Kv7 ion channel activators for focal epilepsy and
neuronal hyperexcitability, and myostatin inhibition for
neuromuscular diseases. More information about Biohaven is
available at www.biohavenpharma.com.
NURTEC, NURTEC ODT and VYDURA are registered trademarks of
Biohaven Pharmaceutical Ireland DAC. Neuroinnovation and NOJECTION
are trademarks of Biohaven Pharmaceutical Holding Company Ltd.
About Vigeo Therapeutics
Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage
immuno-oncology company pioneering novel cancer therapies. The
company is building a first-in-class drug development pipeline
being led by VT1021, its dual-modulating compound that blocks the
CD47 immune checkpoint and reprograms CD36 mediated activities.
Single-agent VT1021 has been investigated in a Phase 1/2 clinical
trial in patients with glioblastoma, pancreatic cancer and other
solid tumors, and is currently progressing to late-stage clinical
development. For more information visit vigeotherapeutics.com or
follow us on LinkedIn and Twitter.
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version on businesswire.com: https://www.businesswire.com/news/home/20220706005204/en/
Global Coalition for Adaptive Research Rachel
Rosenstein-Sisson Rrosenstein.sisson@gcaresearch.org
Biohaven Investors: Jennifer Porcelli VP, Investor
Relations Jennifer.porcelli@biohavenpharma.com
Media: Mike Beyer Sam Brown Inc. mikebeyer@sambrown.com
312-961-2502
Vigeo Therapeutics Investors: Sam Martin 212.600.1902
sam@argotpartners.com
Media: Liza Sullivan 617-340-6073 liza@argotpartners.com
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